Newron Pharmaceuticals is strategically expanding the reach of its innovative drug candidate, evenamide, across Asia through new licensing agreements with Myung In Pharm in South Korea and EA Pharma (a subsidiary of Eisai Co., Ltd.) in Japan and other Asian territories. These agreements mark significant steps in advancing evenamide, a novel modulator of glutamate release, as a potential treatment for schizophrenia, particularly in patients with treatment-resistant schizophrenia (TRS) and those who are poor responders to existing antipsychotic medications.
Myung In Pharm Partnership in South Korea
On January 9, 2025, Newron announced a license agreement with Myung In Pharm, a leading CNS specialist pharmaceutical company in South Korea. Under the agreement, Myung In Pharm will develop, manufacture, and commercialize evenamide in South Korea. A key component of this partnership involves Myung In Pharm contributing 10% of the patients to Newron’s pivotal Phase III trial, covering the associated costs. Additionally, Myung In Pharm will share a percentage of global development costs and handle all regulatory, registration, marketing, and commercialization expenses for evenamide in South Korea. In return, Newron will receive an upfront payment, milestone payments for development and regulatory achievements, and royalties on net sales.
Stefan Weber, CEO of Newron, stated, "We are thrilled to partner with Myung In Pharm in this important clinical trial and to grant them the rights to develop, manufacture and commercialize evenamide in South Korea. Their strong expertise in CNS therapies and their clinical infrastructure will be instrumental in advancing the development of evenamide."
The Phase III trial, expected to begin in H1 2025, is a randomized, double-blind, one-year study comparing evenamide to placebo as an add-on treatment in at least 600 patients with TRS. Newron will coordinate the trial, overseeing design, execution, and data analysis, while Myung In Pharm will enroll patients in South Korea through its network of clinical sites.
EA Pharma Licensing Agreement for Japan and Other Asian Territories
Prior to the Myung In Pharm agreement, on December 13, 2024, Newron announced a license agreement with EA Pharma for the development, manufacture, and commercialization of evenamide in Japan and other designated Asian territories. Under the terms, Newron could receive up to €117 million, including an upfront payment of €44 million, contributions to the Phase III study, regulatory and commercialization milestones, and tiered royalties on net sales.
Hidenori Yabune, President of EA Pharma, commented, "EA is thrilled to acquire the license for evenamide in Japan and other Asian territories. Evenamide has a new mechanism of action involving glutamate regulation and is the first in the world with this mechanism of action to demonstrate therapeutic efficacy in clinical trials."
Evenamide's Clinical Development and Potential
Evenamide is a novel chemical entity designed to modulate the excessive release of glutamate, a neurotransmitter implicated in schizophrenia. It is being developed as an add-on therapy to existing antipsychotics for patients with TRS and those who are poor responders. Approximately 25 million people worldwide are affected by schizophrenia, and a significant portion of these patients do not respond adequately to current treatments.
Data from a potentially pivotal Phase III study (008A) demonstrated that evenamide, as an add-on to second-generation antipsychotics, met its primary endpoint, improvement on the Positive and Negative Syndrome Scale (PANSS), and key secondary endpoint, improvement on the Clinical Global Impressions Scale – Severity (CGI-S), with statistical significance compared to placebo. The trial also showed that evenamide was well-tolerated, without the typical side effects associated with antipsychotics.
Newron's ongoing development program includes a Phase III randomized, double-blind, one-year trial, expected to commence in H1 2025, comparing evenamide to placebo as an add-on treatment in at least 600 patients with TRS. The primary efficacy endpoint will be the change from baseline in PANSS scores at 12 weeks, with continued assessment through week 52 for long-term efficacy and safety data.
These strategic partnerships and the ongoing Phase III trial underscore Newron's commitment to addressing the unmet medical need in schizophrenia treatment and bringing a novel therapeutic option to patients in Asia and beyond.
